IV Dilution &
Medication Reference

MonoFerric (ferric derisomaltose) injection, for intravenous use

Usual Diluents Return to article top

Standard Dilutions [Amt of drug] [Infusion vol] [Infusion rate] Return to article top

Patients ≥ 50 kg:
[ 1000 mg] [100 - 500 ml ] [20-30 minutes]

Patients < 50 kg:
[20 mg/kg actual body weight] [100-500 ml* ] [20-30 min]
(*Minimum concentration > 1 mg/mL)

• Repeat dose if iron deficiency anemia reoccurs.
• The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.
• Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Preparation and Administration

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives.

Each vial of Monoferric is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Monoferric with other drugs has not been established. Monoferric should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Stability: Following dilution with 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored at room temperature for up to 8 hours.
• Extravasation of Monoferric may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Monoferric administration at that site.

WARNINGS Return to article top

DESCRIPTION Return to article top

Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.

Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection.

CLINICAL PHARMACOLOGY: Return to article top

Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

INDICATIONS AND USAGE Return to article top

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

• who have intolerance to oral iron or have had unsatisfactory response to oral iron
• who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

CONTRAINDICATIONS Return to article top

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components [see WARNINGS AND PRECAUTIONS, DESCRIPTION]. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

PRECAUTIONS Return to article top

5.1 Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components [see CONTRAINDICATIONS (4)]. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

5.2 Iron Overload
Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.

ADVERSE REACTIONS Return to article top

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information (pdf)

DOSAGE AND ADMINISTRATION Return to article top

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.

Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions [WARNINGS AND PRECAUTIONS (5.1)].

2.2 Preparation and Administration

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives.

Each vial of Monoferric is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Monoferric with other drugs has not been established. Monoferric should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored at room temperature for up to 8 hours.
• Extravasation of Monoferric may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Monoferric administration at that site.

HOW SUPPLIED Return to article top

Monoferric is a sterile, dark brown, non-transparent aqueous solution available as:

Injection: 1,000 mg iron/10 mL (100 mg/mL) single-dose vial
Injection: 500 mg iron/5 mL (100 mg/mL) single-dose vial
Injection: 100 mg iron/mL single-dose vial

Storage and Stability Return to article top

Vial size Number of vials per carton NDC
1,000 mg/10 mL 1 49442-9310-1
500 mg/5 mL 1 49442-9305-1
100 mg/mL 5 49442-9301-2

Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See the USP controlled room temperature.

Do not freeze.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.